Reliability of Home Uroflowmetery Using a Disposable Digital Device
Primary Purpose
Lower Urinary Tract Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
FloRite
Sponsored by
About this trial
This is an interventional diagnostic trial for Lower Urinary Tract Symptoms focused on measuring urineflow, luts, urine flow, uroflometry, bph
Eligibility Criteria
Inclusion Criteria:
- LUTS patients
- Male 18<Age <65
- Ability to speak, read and understand instructions
- Patient willing to sign an Informed Consent
Exclusion criteria:
- Mentally disabled patients
- Infectious diseases
- Catheterized patients
- Buried penis due to obesity
Sites / Locations
- "Meir" HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FloRite
Arm Description
LUTS patients that used FloRite for home urine flow diagnostics.
Outcomes
Primary Outcome Measures
Usability evaluation of the FloRite™ system with LUTS patients.
Primary outcome measures
• Successful use of FloRite™ system in LUTS patients, defined as:
Successful unpacking and installation
Successful understanding of the user manual
Ability of the patients to operate the device as define by a successful test completion and data transmission
Successful retrieval of the DOK
Absence of:
Device dropping down
Urination outside the container
Urination on the electronic unit
Secondary Outcome Measures
Comparison of Qmax (Max Flow Rate)
Comparison of uroflowmetric parameters of Qmax as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Comparison of Tdelay
Comparison of uroflowmetric parameters of Tdelay as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Comparison of uroflowmetric parameter: T100 - Voiding Time
Comparison of uroflowmetric parameters of T100 as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Comparison of uroflowmetric parameters of TQ - Flow Time
Comparison of uroflowmetric parameters of TQ - Flow Time as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Comparison of uroflowmetric parameters of Tqmax - Time to max Flow
Comparison of uroflowmetric parameters of Tqmax - Time to max Flow as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Comparison of uroflowmetric parameters of Qave
Comparison of uroflowmetric parameters of Qave as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Comparison of uroflowmetric parameters of Vcomp - Voided volume
Comparison of uroflowmetric parameters of Vcomp - Voided volume as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02026674
Brief Title
Reliability of Home Uroflowmetery Using a Disposable Digital Device
Official Title
Reliability of Home Uroflowmetery Using a Disposable Digital Device in Comparison to Standard Clinical Uroflowmetry in Men With LUTS
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flometrica Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The FloRite™ device is a disposable urine flow meter, indicated for use in a home setting.
The device provides Urofowmetry measurements, similar to clinic's measurements. Clinic-based uroflowmetry has some flaws; the setting is artificial and often it is difficult to void at the desired moment. Moreover, a single measurement of the voided parameters is a poor representative of the patient condition due to high variability of the measured parameters. Performing multiple Urofowmetry measurements provides representative and more accurate results, in a more patient-friendly, cost effective method.
Detailed Description
The FloRite™ product is a disposable urine flow meter. The patient needs to urinate into the device and at the end of urination the patient needs to disconnect a USB drive from the device, dispose the device's container and keep the USB drive that contains the test data.
Primary objectives:
• Usability evaluation of the FloRite™ system with LUTS patients.
Secondary objectives:
Comparison of uroflowmetric parameters obtained using home disposable digital uroflowmetry device with standard clinic-based uroflowmetry.
Evaluation of diurnal variations in uroflowmetric parameters obtained using home uroflowmetry
Primary outcome measures
• Successful use of FloRite™ system in LUTS patients, defined as:
Successful unpacking and installation
Successful understanding of the user manual
Ability of the patients to operate the device as define by a successful test completion and data transmission
Successful retrieval of the DOK
Absence of:
Device dropping down
Urination outside the container
Urination on the electronic unit
Secondary outcome measures:
• Comparison of uroflowmetric parameters as measured by
FloRite™ system and standard clinical uroflowmetry as defined by [Time Frame: Days 0, 1, 6 and 7]:
Qmax - Max Flow Rate
• Evaluation of diurnal variations in uroflowmetric parameters obtained using home uroflowmetry as defined by [Time Frame: Days 1, 6]:
Urine flow graph
Tdelay - Delay time
T100 - Voiding Time
TQ - Flow Time
Tqmax - Time to max Flow
Qmax - Max Flow Rate
Qave - Average Flow Rate
Vcomp - Voided Volume Up to 30 completed patients
Inclusion criteria
LUTS patients
Male 18<Age <65
Ability to speak, read and understand instructions
Patient willing to sign an Informed Consent Exclusion criteria
Mentally disabled patients
Infectious diseases
Catheterized patients
Buried penis due to obesity The patients will be consented if found eligible. Prospective, self- controlled, interventional, clinical study
On the baseline visit, after eligibility is confirmed and after consenting the patients, the following steps will be taken:
Standard clinical uroflowmetry
Training how to use the system
Unpacking and setting up the device (supervised by an observer)
The following day, the patient will perform home test with the FloRite™ system. Similar test will be conducted on Day 6 of the study.
The test results will be transferred either by e- mailing the data stored on the DOK or by bringing the DOK itself to the clinic on the 7th day.
On Day 7 of the study, the patients will be asked to return to the clinic for standard clinical uroflowmetry. In addition, the patient will fill a satisfaction questionnaire.
All the measurements must be standard and performed at around the same time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
Keywords
urineflow, luts, urine flow, uroflometry, bph
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FloRite
Arm Type
Experimental
Arm Description
LUTS patients that used FloRite for home urine flow diagnostics.
Intervention Type
Device
Intervention Name(s)
FloRite
Intervention Description
Disposable home use urine flow meter.
Primary Outcome Measure Information:
Title
Usability evaluation of the FloRite™ system with LUTS patients.
Description
Primary outcome measures
• Successful use of FloRite™ system in LUTS patients, defined as:
Successful unpacking and installation
Successful understanding of the user manual
Ability of the patients to operate the device as define by a successful test completion and data transmission
Successful retrieval of the DOK
Absence of:
Device dropping down
Urination outside the container
Urination on the electronic unit
Time Frame
Dec-2014
Secondary Outcome Measure Information:
Title
Comparison of Qmax (Max Flow Rate)
Description
Comparison of uroflowmetric parameters of Qmax as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Time Frame
Dec-2014
Title
Comparison of Tdelay
Description
Comparison of uroflowmetric parameters of Tdelay as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Time Frame
Dec-2014
Title
Comparison of uroflowmetric parameter: T100 - Voiding Time
Description
Comparison of uroflowmetric parameters of T100 as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Time Frame
Dec-2014
Title
Comparison of uroflowmetric parameters of TQ - Flow Time
Description
Comparison of uroflowmetric parameters of TQ - Flow Time as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Time Frame
Dec-2014
Title
Comparison of uroflowmetric parameters of Tqmax - Time to max Flow
Description
Comparison of uroflowmetric parameters of Tqmax - Time to max Flow as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Time Frame
Dec-2014
Title
Comparison of uroflowmetric parameters of Qave
Description
Comparison of uroflowmetric parameters of Qave as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Time Frame
Dec-2014
Title
Comparison of uroflowmetric parameters of Vcomp - Voided volume
Description
Comparison of uroflowmetric parameters of Vcomp - Voided volume as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].
Time Frame
Dec-2014
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
LUTS patients
Male 18<Age <65
Ability to speak, read and understand instructions
Patient willing to sign an Informed Consent
Exclusion criteria:
Mentally disabled patients
Infectious diseases
Catheterized patients
Buried penis due to obesity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeev Cohen, M.Sc.
Phone
+972-52-4471297
Email
zeev@flometrica.cm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Leibovitch, Prof.
Organizational Affiliation
Meir Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Meir" Hospital
City
Kfar-Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilan Leibovitch, Prof.
Phone
+972-9-747-1557
Email
Leibovitchi@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Ilan Leibovitch, Prof.
12. IPD Sharing Statement
Links:
URL
http://www.flometrica.com
Description
Sponsor web site.
Learn more about this trial
Reliability of Home Uroflowmetery Using a Disposable Digital Device
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